Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hitachi, Ltd., Power Systems Group · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073059 | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM | Hitachi, Ltd., Power Systems Group | 2007-12-10 | 41 | 1 |
| K053280 | PROBEAT | Hitachi, Ltd., Power Systems Group | 2006-03-09 | 106 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda